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Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT

Primary Purpose

Keloid

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Keloid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • suspected or confirmed pulmonary fibrosis patients;
  • signed written consent.

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • known allergy against FAPI or RGD
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI-04 PET/CT

Arm Description

All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT.

Outcomes

Primary Outcome Measures

Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 68Ga-RGD PET/CT

Secondary Outcome Measures

FAPI expression and SUV
Correlation between FAPI expression and SUV in PET
therapy response
Change of 68Ga-FAPI PET/CT SUVmax after therapy

Full Information

First Posted
March 2, 2022
Last Updated
June 21, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05275699
Brief Title
Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
Official Title
Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Keloid scars are common benign fibroproliferative reticular dermal lesions. Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.
Detailed Description
Keloid scars are common benign fibroproliferative reticular dermal lesions with unknown etiology and ill-defined management with a high rate of recurrence post-surgery. The progression of keloids is characterized by increased deposition of extracellular matrix proteins, invasion of the surrounding healthy skin, and inflammation. Fibroblast activation protein alpha (FAP-a) and dipeptidyl peptidase IV(DPPIV) are proteases located at the plasma membrane promoting cell invasiveness and tumor growth and have been previously associated with keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment, and follow-up of keloid. This study aims to explore whether FAP plays a role in the mechanisms of scar tissue progression, as well as the diagnostic efficacy of these two imaging agents, and to be able to evaluate relevant treatments for personalized therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
68Ga-FAPI-04 PET/CT
Arm Type
Experimental
Arm Description
All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitors
Intervention Description
Intravenous injection of one dosage of 18.5-22.2MBq (0.5-0.6 mCi)/Kg 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of keloid by PET/CT.
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 68Ga-RGD PET/CT
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
FAPI expression and SUV
Description
Correlation between FAPI expression and SUV in PET
Time Frame
through study completion, an average of 1 year
Title
therapy response
Description
Change of 68Ga-FAPI PET/CT SUVmax after therapy
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected or confirmed pulmonary fibrosis patients; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; known allergy against FAPI any medical condition that in the opinion of the investigator may significantly interfere with study compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

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Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT

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